NYMC Faculty Publications
Safety and Efficacy of Lenabasum in a Phase 2 Randomized, Placebo-Controlled Trial in Adults with Cystic Fibrosis
Author Type(s)
Faculty
DOI
10.1016/j.jcf.2020.09.008
Journal Title
Journal of Cystic Fibrosis
First Page
78
Last Page
85
Document Type
Article
Publication Date
1-2021
Department
Pediatrics
Second Department
Environmental Health Science
Abstract
BACKGROUND: Few therapies specifically address the chronic airway inflammation in cystic fibrosis (CF) that contributes to progressive destruction of lung tissue and loss of lung function. Lenabasum is a cannabinoid type 2 receptor (CB2) agonist that resolves inflammation in a number of in vitro and in vivo models.
METHODS: A Phase 2 double-blind, randomized, placebo-controlled study assessed the safety and tolerability of lenabasum in adults with CF. Subjects with FEV
RESULTS: Of 89 subjects randomized, 51 lenabasum and 23 placebo-only subjects completed the study. No deaths or serious or severe adverse events (AE) were considered related to lenabasum. Most AEs were mild/moderate, and the most common were PEx, hemoptysis, dry mouth, and upper respiratory infection. Three lenabasum and one placebo-only subjects discontinued the study for a treatment related AE. New PEx were treated with intravenous antibiotics in 4.0% of lenabasum-treated vs. 11.4% of placebo-treated subjects, during Weeks 1-4 and 5.2% compared to 13.0% during Weeks 5-12 (p
CONCLUSIONS: The safety findings of lenabasum, coupled with biomarker data, support further testing in a larger study with a longer duration.
Recommended Citation
Chmiel, J. F., Flume, P., Downey, D. G., Dozor, A. J., Colombo, C., Mazurek, H., Sapiejka, E., Rachel, M., Constantine, S., Conley, B., Dgetluck, N., Dinh, Q., White, B., Elborn, J. S., & Lenabasum JBT101-Cf001-Study Group. (2021). Safety and Efficacy of Lenabasum in a Phase 2 Randomized, Placebo-Controlled Trial in Adults with Cystic Fibrosis. Journal of Cystic Fibrosis, 20 (1), 78-85. https://doi.org/10.1016/j.jcf.2020.09.008
